Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation

NCT02748720 | Completed DMC

• 1 other identifier: 2014-05
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.

Conditions

Infant, Premature

Keywords

Premature; Respiratory Function Monitor

Outcome Measures

Primary Outcomes (1)

• Reduce the need for surfactant.

  The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.

  through study completion, an average of 3 days

Secondary Outcomes (6)

• Need for intubation and intermittent mechanical ventilation (iMV)

  through study completion, an average of 3 days

• Incidence of dysplasia bronchopulmonary

  through study completion, an average of 1 year

• CPAP on admission to NICU

  through study completion, an average of 1 day

• Incidence of mortality

  through study completion, an average of 1 year

• Measure and get desired tidal volume to optimize resuscitation

  through study completion, an average of 1 year

Study Arms (2)

RFM Visible

EXPERIMENTAL

Patients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe.

Other: RFM (device) Visible

RFM No Visible

NO INTERVENTION

Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks

Interventions

RFM (device) Visible OTHER

Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume

RFM Visible

Eligibility Criteria

• Age: Up to 1 Minute
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.

You may not qualify if:

• Congenital Malformations or Chromosomal Aberrations
• Less Than 22 Weeks
• Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve
• Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph\<7.00)
• reanimation unrecorded with video
• no obtained informed consent

Sponsors & Collaborators

• Manuel Sanchez Luna: lead

Study Sites (1)

HGU Gregorio Marañón

Madrid, Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gonzalo Zeballos, MD

  Gregorio Marañón Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 22, 2016
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)